RecruitingPhase 1Phase 2NCT07704580

Phase 1b/2 Study of IV Sarilumab in Adult With RA

A Randomized Open Label, Phase 1b/2 Study to Evaluate Intravenous Administration With Long Dosing Interval Regimens of Sarilumab in Adult Participants With Rheumatoid Arthritis


Sponsor

Sanofi

Enrollment

140 participants

Start Date

Jul 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1/Phase 2 study with: * 5-arms design for Part A; * and a single arm for Part B. The purpose of this study is to measure PK parameters and safety with sarilumab intravenous (IV) with or without concomitant oral conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) in male and female participants with moderately to severely active rheumatoid arthritis aged 18 years of age or older. Study details include: * The study duration will be up to 64 weeks. * The treatment duration will be up to 6 months for each study phase. * Part A has 10 visits, including a post-treatment end of study (EOS) follow-up visit. * For participants entering the open label extension to receive the approved 200 mg sarilumab every two weeks (Q2W) dose, there will be 3 additional study visits. * For the intra-study sarilumab 200 mg Q2W subcutaneous (SC) arm, participants will be evaluated over the course of 24 weeks plus post-treatment EOS follow-up visit following the schedule of activities (SoA) of Part A from Day -1 to Day 29 (total of 8 visits) and the SoA of Part B from Week 4 to Week 24 (total of 8 visits) and a post-treatment end of study (EOS) follow-up visit at Week 30 (Part B) for a total of 17 visits, including a post-treatment EOS follow-up visit. * Part B has 13 visits, including a post-treatment EOS follow-up visit.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Sarilumab, SAR153191 IV and a drug called Sarilumab, SAR153191 SC for people with rheumatoid arthritis. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSarilumab, SAR153191 SC

Pharmaceutical form: solution for injection. Route of administration: subcutaneous.

DRUGSarilumab, SAR153191 IV

Route of administration: intravenous.


Locations(2)

Encore Medical Research - Hollywood- Site Number : 8400010

Hollywood, Florida, United States

ClinRx Research - Plano- Site Number : 8400015

Plano, Texas, United States

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NCT07704580


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